FDA to drop two-study requirement for new drug approvals, aiming to speed access
The FDA officials predicted the shift would lead to “a surge in drug development.”
FDA
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FDA rejects Lilly drug for eczema due to inspection issues at outside manufacturer
Eli Lilly and Co. just hit another bump in the road in its quest to push deeper into treatments for skin diseases, the third setback this year for the Indianapolis-based drugmaker from the U.S Food and Drug Administration.
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Fishers biotech firm lands additional FDA approval for imaging product
Illuccix was first approved by the FDA in December 2021. The imaging agent is designed to target and “light up” cancerous cells, making it easier for oncologists to determine through a PET scan if the cells have spread to areas outside the prostate.
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FDA approves Lilly diabetes drug that helps patients lose weight
The drug has been closely watched by medical professionals and is viewed by financial analysts as a possible blockbuster, with potential annual sales in the billions of dollars.
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Lilly says experimental drug helped patients lose up to 22% of body weight
The drug, called tirzepatide, has been closely watched by medical professionals and is viewed by financial analysts as possible blockbuster, with potential annual sales in the billions of dollars.
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FDA declines to review Moderna application for first mRNA-based flu vaccine
Moderna President Stephen Hoge said that the company had previously engaged with the FDA on the trial design and that the agency had indicated it would be acceptable.
Companies can now claim ‘no artificial colors’ if they add plant-based color to food
Health advocates have long called for the removal of artificial dyes from foods, citing inconclusive studies that found they could cause neurobehavioral problems, including hyperactivity and attention issues in some children.
House lawmaker raises new concerns over FDA’s ultra-fast drug review program
Under the program, drugmakers are promised expedited reviews of one to two months for new medicines that support “national interests.”
Lilly receives FDA’s breakthrough therapy designation for ovarian cancer drug
Ovarian cancer is the fifth-leading cause of cancer death among women in the United States.
Popular weight-loss drugs shouldn’t carry suicide warnings, FDA says
U.S. Food and Drug Administration officials say a comprehensive review “found no increased risk” related to suicide among users of the GLP-1 drugs, including Eli Lilly and Co.’s Zepbound, used to treat obesity.
US regulators approve Wegovy pill for weight loss, giving Novo Nordisk an edge over Lilly
Novo Nordisk’s Wegovy pills are expected to be available within weeks, while Indianapolis-based Eli Lilly and Co. waits for approval for its daily GLP-1 pill, orforglipron.
IU doctor takes expert role as FDA weighs changes to testosterone therapy regulation
Dr. Helen Bernie said on a Dec. 10 panel hosted by the U.S. Food and Drug Administration that serum testosterone “is one of the most powerful yet underutilized biomarkers for men’s health.”
Big retailers didn’t pull ByHeart baby formula fast enough after botulism recall, FDA says
The U.S. Food and Drug Administration said four companies continued to sell the infant formula for days or weeks, despite a Nov. 11 recall of all products in the outbreak that has sickened more than 50 babies in 19 states.
California company recalls nearly 245,000 pounds of pasta tied to listeria outbreak
The company recalled thousands of cases of heat-and-eat linguine, fettucine, penne and other pastas sold at grocery stores nationwide.
Trump’s plan for drug advertising crackdown faces many hurdles
President Donald Trump signed a memo Tuesday that directs the FDA and other agencies to step up enforcement against ubiquitous prescription drug ads on TV, websites and social media.
FDA OKs updated COVID shots with limits for some children, adults
The revamped vaccines target a newer version of the continuously evolving virus and are set to begin shipping soon.
Health officials crack down on kratom-related products after complaints from supplement industry
U.S. health officials are warning Americans about the risks of an opioid-like ingredient increasingly added to energy drinks, gummies and supplements sold at gas stations and convenience stores, recommending a nationwide ban.
FDA names former pharmaceutical exec to oversee drug program
Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s Center for Drug Evaluation and Research, which regulates the safety and effectiveness of all U.S. drugs.
FDA considers trading faster drug reviews for lower prices
The idea could help the administration achieve one of President Donald Trump’s main health-care goals: ensuring foreign countries aren’t getting a better deal on drugs.
FDA begins sharing rejection letters drugmakers often kept secret
Investors have long asked the FDA to share its reasons for rejecting drugs, arguing that companies can use the agency’s silence on the matter to mislead the market.
Nestle says it will remove artificial dyes from US foods by 2026
Nestle joins Kraft Heinz and General Mills as major food companies to pledge they would remove artificial dyes from their U.S. products.
FDA to offer faster drug reviews to companies promoting ‘national priorities’
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.
FDA to limit COVID vaccine approval to older adults, those with medical conditions
FDA leaders estimate more than 100 million Americans would still be eligible for the shots under the new framework.
FDA to phase out 8 artificial dyes from food supply
It would be a sweeping change for U.S. food producers, who would likely replace the dyes with natural substitutes.